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  <title>启明星 | 推想医疗脑卒中AI产品获NMPA三类证，成国内首个斩获NMPA与FDA中美双认证产品 | 启明创投</title>
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            <h2 class="font-medium">启明星 | 推想医疗脑卒中AI产品获NMPA三类证，成国内首个斩获NMPA与FDA中美双认证产品</h2>
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          <span class="date-display-single">2022/07/06</span>    
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          启明创投    
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          <p class="rtejustify"><span style="font-size:16px;">根据国家药品监督管理局（NMPA）官网信息，近日，<strong>启明创投投资企业推想医疗颅内出血CT图像辅助分诊软件正式获批国家药品监督管理局医疗AI三类证，</strong>可对颅脑CT平扫影像进行显示、处理、测量出血体积，用于对超急性期、急性期颅内出血患者的分诊提示。<strong>这是推想医疗在心脑血管领域的首张NMPA三类证，去年8月，推想医疗脑卒中产品（InferRead CT Stroke）已经通过了美国FDA认证。</strong></span></p>

<p class="rtejustify"><span style="font-size:16px;">自此，<strong>推想医疗脑卒中AI产品成为国内首个斩获NMPA与FDA“中美双认证”产品，</strong>获得了国内外药监机构的一致肯定。并且，<strong>推想医疗脑卒中项目已入选工信部、国家卫健委5G+医疗健康应用试点。</strong></span></p>

<p class="rtecenter"><img alt="" src="/sites/default/files/news/%E5%90%AF%E6%98%8E%E6%98%9F%20%E6%8E%A8%E6%83%B3%E5%8C%BB%E7%96%97%E8%84%91%E5%8D%92%E4%B8%ADAI%E4%BA%A7%E5%93%81%E8%8E%B7NMPA%E4%B8%89%E7%B1%BB%E8%AF%81%EF%BC%8C%E6%88%90%E5%9B%BD%E5%86%85%E9%A6%96%E4%B8%AA%E6%96%A9%E8%8E%B7NMPA%E4%B8%8EFDA%E4%B8%AD%E7%BE%8E%E5%8F%8C%E8%AE%A4%E8%AF%81%E4%BA%A7%E5%93%81.jpg" style="width: 1080px; height: 839px;" /></p>

<p class="rtejustify"><span style="font-size:16px;">不到两个月前，<strong>推想医疗获得了NMPA第一张多类型胸部骨折AI三类证，一举囊括肺结节、肺炎、胸部骨折的“全三类”NMPA认证，实现“胸肺三件套”黄金组合，</strong>助力中国胸部多种疾病一查多筛。加上此次推想医疗在心脑血管领域获得的首张NMPA三类证，这意味着在<strong>心脑领域与胸肺部领域，推想医疗都已经拿到了NMPA认证，商业化进程再获重大突破。</strong></span></p>

<p class="rtejustify"><span style="font-size:16px;">目前，<strong>推想医疗的肺结节AI产品与脑卒中AI产品均已获得中国NMPA三类证和美国FDA的双重认证。</strong></span></p>

<p class="rtejustify"><strong><span style="font-size:18px;">01/<br />
脑卒中救治<br />
时间是关键</span></strong></p>

<p class="rtejustify"><span style="font-size:16px;">脑卒中是一种急性脑血管疾病，是由于脑部血管突然破裂或血管阻塞导致血液不能流入大脑而引起脑组织损伤的一组疾病，包括缺血性卒中和出血性卒中。<strong>脑卒中是我国成人致死､致残的首要病因，且呈逐年上升趋势，给社会和家庭带来了沉重的负担。</strong></span></p>

<p class="rtejustify"><span style="font-size:16px;"><strong>脑卒中的救治原则是“时间就是生命”，每一秒都直接影响大脑的病变速度。</strong>然而医疗资源不足、卒中筛查难普及，卒中急救到院久、评估慢、环节多、治疗晚、标准化低等问题仍然存在。</span></p>

<p class="rtejustify"><span style="font-size:16px;"><strong>推想医疗在深度学习脑卒中辅助诊断方面取得了多项科研成果，</strong>早在2019年推想医疗利用深度学习技术辅助出血性脑卒中血肿体积测量以及缺血性脑卒中Alberta卒中项目早期CT评分（Alberta Stroke Program Early CT Score, ASPECTS）评估的科研成果就分别在国际放射学顶级会议——欧洲放射学大会（European Congress of Radiology, ECR）和北美放射学会年会（Radiological Society of North America, RSNA）上以口头报告的形式进行发表。</span></p>

<p class="rtejustify"><span style="font-size:16px;">推想医疗累计在脑卒中科研领域发表了7篇ECR和RSNA国际顶级会议摘要、1篇中文核心期刊论文，以及与北京天坛医院、上海复旦大学附属中山医院合作发表一篇SCI论文。</span></p>

<p class="rtejustify"><strong><span style="font-size:18px;">02/<br />
脑卒中CT一站式AI解决方案<br />
支持卒中急救精准诊断决策</span></strong></p>

<p class="rtejustify"><span style="font-size:16px;">基于我国卒中防治痛点，以及6年来在AI和卒中影像领域的深厚积累，推想医疗推出了脑卒中CT一站式AI解决方案。该解决方案支持对NCCT、CTP和CTA多模态影像的AI辅助评估。<strong>不仅能够实现对卒中高危人群早期的精准筛查、智能随访，还具备对超急性期、急性期卒中患者的快速分诊，以及在卒中急救中提供快速、精准的诊断决策支持。</strong></span></p>

<p class="rtejustify"><span style="font-size:16px;"><strong>脑卒中CT一站式AI解决方案包含出血性卒中AI精准诊断模块及缺血性卒中AI快速定量分析模块。</strong>其中出血性卒中AI精准诊断模块包括颅内出血CT影像辅助分诊系统、颅内动脉瘤辅助分析系统；缺血性卒中AI快速定量分析模块包括CT智能ASPECTS评分系统、智能CTP量化分析系统、智能CTA辅助诊断系统。无论是缺血性卒中还是出血性卒中，推想医疗均可提供基于AI的解决方案，满足卒中急救快速评估的需求。</span></p>

<p class="rtejustify"><strong><span style="font-size:16px;">推想医疗脑卒中CT一站式AI解决方案具备以下优势：</span></strong></p>

<ul>
	<li class="rtejustify"><span style="font-size:16px;"><strong>智能：</strong>自动识别，自动分割，自动重建，自动计算</span></li>
	<li class="rtejustify"><span style="font-size:16px;"><strong>精准：</strong>精准检出病灶，多维展示，为医生提供丰富的诊断信息</span></li>
	<li class="rtejustify"><span style="font-size:16px;"><strong>高效：</strong>AI自动重建，后处理效率提升10倍以上</span></li>
	<li class="rtejustify"><span style="font-size:16px;"><strong>结构化：</strong>图文报告标准化输出并与医院PACS和HIS无缝对接</span></li>
</ul>

<p class="rtejustify"><strong><span style="font-size:18px;">03/<br />
推想医疗脑卒中项目入选<br />
工信部、卫健委5G+医疗健康应用试点</span></strong></p>

<p class="rtejustify"><span style="font-size:16px;">对于脑卒中患者来说，尽早诊断、尽早治疗是非常重要的。在医院的诊疗过程中，传统头颈CTA检查一般需要两次CT扫描，减影去骨与手动重建需要15-20分钟，10分钟进行报告编写与胶片排版，最后进行报告审核，这个流程往往需要30分钟。</span></p>

<p class="rtejustify"><span style="font-size:16px;">推想医疗脑卒中CT一站式AI解决方案是基于一次CT扫描，AI自动实现“血管重建+病灶分析+胶片排版+结构化报告生成”，最后进行报告审核，<strong>此流程只需5分钟，为卒中抢救赢得了宝贵的时间。</strong></span></p>

<p class="rtecenter"><img alt="" src="/sites/default/files/news/%E5%90%AF%E6%98%8E%E6%98%9F%20%E6%8E%A8%E6%83%B3%E5%8C%BB%E7%96%97%E8%84%91%E5%8D%92%E4%B8%ADAI%E4%BA%A7%E5%93%81%E8%8E%B7NMPA%E4%B8%89%E7%B1%BB%E8%AF%81%EF%BC%8C%E6%88%90%E5%9B%BD%E5%86%85%E9%A6%96%E4%B8%AA%E6%96%A9%E8%8E%B7NMPA%E4%B8%8EFDA%E4%B8%AD%E7%BE%8E%E5%8F%8C%E8%AE%A4%E8%AF%81%E4%BA%A7%E5%93%811.jpg" style="width: 1080px; height: 810px;" /><br />
<span style="color:#7f8c8d;"><span style="font-size:8px;">5G+AI+移动CT卒中急救走上救护车</span></span></p>

<p class="rtejustify"><span style="font-size:16px;">2021年9月，工业和信息化部、国家卫生健康委员会联合公布了全国《5G+医疗健康应用试点项目名单》，推想医疗参与的脑卒中项目成功入选。12月，中国西部5G+急性卒中天网智慧医疗急救体系建设项目在四川省医学科学院·四川省人民医院正式启动，<strong>5G、AI、移动CT、智能救护车、数字化天网共同支撑起了中国西部5G+卒中急救天网工程，实现“上车即入院”，AI的融入给5G+技术插上了翅膀，让卒中患者尽早接受救治，同时减少并发症，降低死亡率，降低病人及其家庭的经济负担。</strong></span></p>

<p class="rtecenter"><img alt="" src="/sites/default/files/news/%E5%90%AF%E6%98%8E%E6%98%9F%20%E6%8E%A8%E6%83%B3%E5%8C%BB%E7%96%97%E8%84%91%E5%8D%92%E4%B8%ADAI%E4%BA%A7%E5%93%81%E8%8E%B7NMPA%E4%B8%89%E7%B1%BB%E8%AF%81%EF%BC%8C%E6%88%90%E5%9B%BD%E5%86%85%E9%A6%96%E4%B8%AA%E6%96%A9%E8%8E%B7NMPA%E4%B8%8EFDA%E4%B8%AD%E7%BE%8E%E5%8F%8C%E8%AE%A4%E8%AF%81%E4%BA%A7%E5%93%812.jpg" style="width: 1080px; height: 720px;" /><br />
<span style="color:#7f8c8d;"><span style="font-size:8px;">推想医疗等单位在项目启动仪式上获颁首批联合申报单位证书</span></span></p>

<p class="rtejustify"><span style="font-size:16px;">数据显示，<strong>推想医疗脑卒中CT一站式AI解决方案不仅将（NCCT、CTP、CTA）影像的阅片效率提高10倍以上，诊断准确性也达到三甲医院专家平均水平，</strong>并且自动输出量化分析结果，获得了影像、临床专家的广泛好评。</span></p>

<p class="rtejustify"><span style="font-size:16px;">在脑卒中AI项目入选工信部、国家卫健委重点项目之前，推想医疗在AI医疗创新上的能力就已得到工信部等多个国家部委的肯定，比如在2020年，<strong>推想医疗就在上千家企业中突围而出，凭借胸肺一筛多查的优异表现，以“医疗影像辅助诊断系统赛道”第一名的成绩荣获揭榜优胜单位。</strong></span></p>

<p class="rtejustify"><span style="font-size:16px;"><strong>推想医疗创始人兼董事长陈宽表示：“这是推想医疗在两个月内获得的第二张NMPA三类证，此前获得了NMPA第一张多类型胸部骨折AI三类证，组成了囊括肺结节、肺炎、胸部骨折的‘胸肺三件套’黄金组合。</strong>本次获批，不仅是对推想医疗‘一横一纵’产品战略最好的诠释，也更坚定了我们持续深耕的决心。脑卒中AI产品对社会、对患者意义重大，我们必将全力以赴助力卒中临床诊疗体系建设，为我国卒中防治事业贡献力量。”</span></p>

<p class="rteright"><br />
<span style="font-size:16px;">相关阅读</span></p>

<p class="rtecenter"><span style="font-size:18px;"><strong>推想医疗脑卒中AI产品简介</strong></span></p>

<p class="rtecenter"><img alt="" src="/sites/default/files/news/%E5%90%AF%E6%98%8E%E6%98%9F%20%E6%8E%A8%E6%83%B3%E5%8C%BB%E7%96%97%E8%84%91%E5%8D%92%E4%B8%ADAI%E4%BA%A7%E5%93%81%E8%8E%B7NMPA%E4%B8%89%E7%B1%BB%E8%AF%81%EF%BC%8C%E6%88%90%E5%9B%BD%E5%86%85%E9%A6%96%E4%B8%AA%E6%96%A9%E8%8E%B7NMPA%E4%B8%8EFDA%E4%B8%AD%E7%BE%8E%E5%8F%8C%E8%AE%A4%E8%AF%81%E4%BA%A7%E5%93%813.jpg" style="width: 1080px; height: 5000px;" /></p>
    
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